Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

Device	VNS THERAPY SYSTEM
Generic Name	Stimulator, autonomic nerve, implanted for epilepsy
Applicant	LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058
PMA Number	P970003
Date Received	01/27/1997
Decision Date	07/16/1997
Product Codes	LYJ MUZ
Docket Number	98M-0140
Notice Date	03/04/1998
Advisory Committee	Neurology
Expedited Review Granted?	Yes
Combination Product	No
Predetermined Change Control Plan Authorized	No
Recalls	CDRH Recalls
Approval Order Statement   Approval for the NeuroCybernetic Prosthesis (NCP(R)) System which includes the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool, and NCP System Accessories.
Summary	Summary of Safety and Effectiveness
Supplements:	S030 S031 S032 S033 S034 S039 S040 S041 S042 S055 S078 S079  S080 S081 S082 S083 S084 S085 S086 S053 S054 S047 S048 S049  S050 S051 S052 S063 S064 S010 S011 S012 S013 S014 S015 S016  S017 S018 S019 S020 S021 S022 S099 S008 S009 S087 S088 S089  S090 S091 S092 S093 S094 S037 S038 S062 S071 S069 S070 S200  S207 S208 S227 S228 S229 S210 S024 S025 S139 S140 S141 S142  S143 S152 S153 S161 S162 S163 S180 S181 S182 S183 S184 S148  S172 S187 S188 S177 S156 S157 S158 S112 S113 S114 S101 S102  S103 S104 S075 S076 S077 S106 S109 S108 S110 S111 S095 S196  S197 S198 S199 S205 S206 S201 S202 S203 S211 S209 S164 S214  S223 S225 S226 S235 S245 S244 S218 S215 S216 S233 S230 S231  S232 S224 S219 S221 S222 S128 S129 S130 S120 S121 S122 S001  S002 S003 S004 S005  S160 S134 S135 S136 S137 S138 S179  S150 S151 S072 S073 S074 S170 S165 S186 S155 S100 S026 S027  S204 S166 S167 S213 S236 S237 S238 S239 S240 S234 S123 S124  S125 S126 S131 S132 S133 S127 S146 S147 S243 S246 S154 S173  S175 S174 S176 S185 S149 S178 S168 S169 S105 S115 S116 S117  S118 S241 S247 S144 S145 S159 S119 S035 S045 S046 S057 S058  S059 S060 S065 S066 S067 S068 S096 S097 S098 S252 S248 S249  S250 S251 S253 S254 S189 S190 S191 S192 S193 S194 S195